Acute PainBOLPAPNCT05819476
Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults
A study testing OLP-injection, Scripted Evidence-based treatment rationale and Experimental model of acute pain in people with Acute Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- OLP-injection, Scripted Evidence-based treatment rationale and Experimental model of acute pain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Mar 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (ASA Class I or II), aged 18 to 65 years
- BMI between 18 and 25kg/m2
- Able to understand the study and the NRS
- Able to give informed consent
Who cannot join
- Participation in a previous open-label placebo study; for Part 2, this includes Part 1 of this study
- Regular intake of medications or drugs potentially interfering with pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/ noradrenaline reuptake inhibitors, corticosteroids)
- Neuropathy
- Chronic pain
- Neuromuscular disease
- Dermatological disease (i.e. Atopic Dermatitis)
- Psychiatric disease
- Pregnancy / Lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Basel (USB); Department of Anaesthesiology
Basel, 4031
Tobias Schneider, MD, +41 61 328 65 43, tobias.schneider@usb.ch
Tobias Schneider, MD
About this study
This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated
Read the detailed description
Pain is highly prevalent in hospital settings. Standard systemic treatment for acute pain consists mainly of basic analgesia. The use of these drugs is often restricted due to their contraindications. Placebo is used nowadays to describe sham treatments and "inert" substances like sugar pills and saline injections. Placebos are proven to elicit clinically significant effects in various conditions, including pain. Ethical concerns about the use of deceptive placebos have prevented their implementation in clinical practice. A possibility to address this issue would be to prescribe placebos openly, that means, without deception. This randomized crossover study evaluates the efficacy of open-label placebo (OLP) in acute pain. Subjective pain ratings and areas of hyperalgesia and allodynia will be measured in a well-established experimental pain model (intradermal electrical stimulation model evoking pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment) and analgesia elicited by OLP injections will be investigated.
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated (which leaves the last group a choice over when they would like to have the placebo "booster").
- Conditions
- Acute Pain
- Being tested
- OLP-injection, Scripted Evidence-based treatment rationale, Experimental model of acute pain
- Keywords
- Open-Label Placebo (OLP), OLP analgesia, acute pain, hyperalgesia, allodynia
- Medical subject headings
- Acute Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLP-injectionProcedure or surgery
Open-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions.
Scripted Evidence-based treatment rationaleOther
As a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations.
Experimental model of acute painOther
Experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention) | Other | In Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 2. Visit 1 (No treatment) will be the control of the study intervention. Receives: Procedure: OLP-injection; Other: Scripted Evidence-based treatment rationale; Other: Experimental model of acute pain |
| Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment) | Other | In Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 1. Visit 2 (No treatment) will be the control of the study intervention. Receives: Procedure: OLP-injection; Other: Scripted Evidence-based treatment rationale; Other: Experimental model of acute pain |
| Part 2/ Group A: 1x OLP (Control) | Other | In Part 2, the Group A (Control) receives just one single OLP injection and no repetition. Receives: Procedure: OLP-injection; Other: Scripted Evidence-based treatment rationale; Other: Experimental model of acute pain |
| Part 2/ Group B: 2x OLP; booster time fixed | Other | In Part 2, Group B participants will receive two injections, the first at twenty minutes after start of the experiment, and the second at a time point derived from Part 1 (if data is inconclusive; at 100 minutes).
For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain. Receives: Procedure: OLP-injection; Other: Scripted Evidence-based treatment rationale; Other: Experimental model of acute pain |
| Part 2/ Group C: 2x OLP; booster on- demand | Other | In Part 2, Group C participants will receive two injections, the first at twenty minutes after start of the experiment, and the second on demand.
For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain. Receives: Procedure: OLP-injection; Other: Scripted Evidence-based treatment rationale; Other: Experimental model of acute pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Change in Area under the Pain Curve (AUPC)
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain) during three hours after administering an OLP
Measured: During three hours after administering an OLP
Part 2: Change in Area under the Pain Curve (AUPC)
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain). Comparison of the AUPCs of subjects receiving just one OLP injection with subjects additionally receiving one repetition of OLP administration at a time point derived from Part 1 and subjects getting the second OLP injection on-demand.
Measured: During three hours after administering an OLP
Secondary outcomes (3)
Part 1 and 2: Change in subjective pain ratings on each measurement point using the numeric rating scale (NRS)
Change in subjective pain ratings on each measurement point using the numeric rating scale (NRS); NRS; 0 = no pain, 10 = worst imaginable pain) every five minutes after OLP administration)
Measured: Up to 200 minutes after electrical pain stimulation
Part 1 and 2: Change in Area under the Curve (AUC) of area of hyperalgesia
Change in Area under the Curve (AUC) of area of hyperalgesia comparing the intervention and control (no treatment) visit. Pinprick hyperalgesia will be assessed every 10 minutes after OLP administration) using a 600 millinewton (mN) von Frey filament.
Measured: Up to 200 minutes after electrical pain stimulation
Part 1 and 2: Change in Area under the Curve (AUC) of area of allodynia
Change in Area under the Curve (AUC) of area of allodynia comparing the intervention and control (no treatment) visit. Allodynia will be determined using a dry cotton swab every 10 minutes after OLP administration).
Measured: Up to 200 minutes after electrical pain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start23 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The first part of this study is designed as a confirmatory, randomized, two-arm, assessor-blinded cross-over trial in a monocentric setup at the University Hospital of Basel. The second part is designed as a proof-of-concept, randomized, controlled, three-arm trial in a monocentric setup at the University Hospital of Basel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Schneider, MD, Principal investigator, Department of Anaesthesiology, University Hospital of Basel (USB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819476
- Sponsor's protocol ID
- 2023-00296; am23Schneider
- Other IDs
- 2023
- Acronym
- BOLPAP
- Status last verified
- Jan 2025
- First submitted
- 20 Mar 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Leeuw M, Laager M, Gaab J, Ruppen W, Schneider T. Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial. Front Med (Lausanne). 2024 Feb 14;11:1238878. doi: 10.3389/fmed.2024.1238878. eCollection 2024.
PubMed 38420356
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Open-Label Placebo Effects in Acute Induced Pain in Healthy Adults
- ClinicalTrials.gov ID
- NCT05819476
- Acronym / sponsor ID
- BOLPAP / 2023-00296; am23Schneider
- Conditions
- Acute Pain
- Keywords
- Open-Label Placebo (OLP), OLP analgesia, acute pain, hyperalgesia, allodynia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the effect of open-label placebo (OLP) application on acute pain in an experimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment).
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated
Detailed description
Pain is highly prevalent in hospital settings. Standard systemic treatment for acute pain consists mainly of basic analgesia. The use of these drugs is often restricted due to their contraindications. Placebo is used nowadays to describe sham treatments and "inert" substances like sugar pills and saline injections. Placebos are proven to elicit clinically significant effects in various conditions, including pain. Ethical concerns about the use of deceptive placebos have prevented their implementation in clinical practice. A possibility to address this issue would be to prescribe placebos openly, that means, without deception. This randomized crossover study evaluates the efficacy of open-label placebo (OLP) in acute pain. Subjective pain ratings and areas of hyperalgesia and allodynia will be measured in a well-established experimental pain model (intradermal electrical stimulation model evoking pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment) and analgesia elicited by OLP injections will be investigated.
In Part 1 duration of OLP analgesia will be examined, and onset and size of the effect will be reevaluated.
In Part 2 of this study outcomes between subjects receiving one OLP injection, subjects receiving one repetition of the injection on a fixed time point and subjects receiving one repetition of the injection on-demand will be evaluated (which leaves the last group a choice over when they would like to have the placebo "booster").
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- The first part of this study is designed as a confirmatory, randomized, two-arm, assessor-blinded cross-over trial in a monocentric setup at the University Hospital of Basel. The second part is designed as a proof-of-concept, randomized, controlled, three-arm trial in a monocentric setup at the University Hospital of Basel.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention) | Other | Procedure: OLP-injection, Other: Scripted Evidence-based treatment rationale, Other: Experimental model of acute painIn Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 2. Visit 1 (No treatment) will be the control of the study intervention. |
| Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment) | Other | Procedure: OLP-injection, Other: Scripted Evidence-based treatment rationale, Other: Experimental model of acute painIn Part 1, participants will receive one injection (administration of open-label placebo injections without any active ingredient (5 ml 0.9% saline)) at twenty minutes after start of the experiment during the intervention visit 1. Visit 2 (No treatment) will be the control of the study intervention. |
| Part 2/ Group A: 1x OLP (Control) | Other | Procedure: OLP-injection, Other: Scripted Evidence-based treatment rationale, Other: Experimental model of acute painIn Part 2, the Group A (Control) receives just one single OLP injection and no repetition. |
| Part 2/ Group B: 2x OLP; booster time fixed | Other | Procedure: OLP-injection, Other: Scripted Evidence-based treatment rationale, Other: Experimental model of acute painIn Part 2, Group B participants will receive two injections, the first at twenty minutes after start of the experiment, and the second at a time point derived from Part 1 (if data is inconclusive; at 100 minutes). For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain. |
| Part 2/ Group C: 2x OLP; booster on- demand | Other | Procedure: OLP-injection, Other: Scripted Evidence-based treatment rationale, Other: Experimental model of acute painIn Part 2, Group C participants will receive two injections, the first at twenty minutes after start of the experiment, and the second on demand. For every subsequent OLP administration, patients will be reminded of the inertness of the injection and that this injection might help with regulating pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers (ASA Class I or II), aged 18 to 65 years
- BMI between 18 and 25kg/m2
- Able to understand the study and the NRS
- Able to give informed consent
Key exclusion criteria (8 listed)
- Participation in a previous open-label placebo study; for Part 2, this includes Part 1 of this study
- Regular intake of medications or drugs potentially interfering with pain sensation (analgesics, opioids, antihistamines, calcium and potassium channel blockers, serotonin/ noradrenaline reuptake inhibitors, corticosteroids)
- Neuropathy
- Chronic pain
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLP-injectionOpen-label placebo injections without any active ingredient (5 ml 0.9% saline). All participants will be informed that the administered injections are placebo infusions. | Procedure or surgery | Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention), Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment), Part 2/ Group A: 1x OLP (Control), Part 2/ Group B: 2x OLP; booster time fixed, Part 2/ Group C: 2x OLP; booster on- demand |
| Scripted Evidence-based treatment rationaleAs a second component the intervention will consist of an evidence-based treatment rationale, which will be delivered to patients receiving the intervention prior to the OLP-injections, explaining placebo analgesia in pain in general and specifically in OLP. In the context of OLP treatments this rationale is important in order to create a mental state of positive expectations. | Other | Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention), Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment), Part 2/ Group A: 1x OLP (Control), Part 2/ Group B: 2x OLP; booster time fixed, Part 2/ Group C: 2x OLP; booster on- demand |
| Experimental model of acute painExperimental model of acute pain (simulating wound pain: this installation will apply monophasic, rectangular electrical pulses of 0.5ms duration with alternating polarity at 2 Hz frequency. The current will be increased to target a pain rating of 6 of 10 on the NRS (0 = no pain, 10 = worst imaginable pain). Three further adjustments in current will be made every 5 minutes for the next 15 minutes to compensate for habituation. This final current will be kept constant until the end of the particular experiment). | Other | Part 1: Visit 1 (No treatment) followed by Visit 2 (OLP intervention), Part 1: Visit 1 (OLP intervention) followed by Visit 2 (No treatment), Part 2/ Group A: 1x OLP (Control), Part 2/ Group B: 2x OLP; booster time fixed, Part 2/ Group C: 2x OLP; booster on- demand |
Primary outcome
Part 1: Change in Area under the Pain Curve (AUPC)
Time frame: During three hours after administering an OLP
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain) during three hours after administering an OLP
Part 2: Change in Area under the Pain Curve (AUPC)
Time frame: During three hours after administering an OLP
Area under the Pain Curve (AUPC) using the numeric rating scale (NRS; 0 = no pain, 10 = worst imaginable pain). Comparison of the AUPCs of subjects receiving just one OLP injection with subjects additionally receiving one repetition of OLP administration at a time point derived from Part 1 and subjects getting the second OLP injection on-demand.
3 secondary outcomes
Part 1 and 2: Change in subjective pain ratings on each measurement point using the numeric rating scale (NRS)
Time frame: Up to 200 minutes after electrical pain stimulation
Part 1 and 2: Change in Area under the Curve (AUC) of area of hyperalgesia
Time frame: Up to 200 minutes after electrical pain stimulation
Part 1 and 2: Change in Area under the Curve (AUC) of area of allodynia
Time frame: Up to 200 minutes after electrical pain stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 38420356de Leeuw M, Laager M, Gaab J, Ruppen W, Schneider T. Boosting open-label placebo effects in acute induced pain in healthy adults (BOLPAP-study): study protocol of a randomized controlled trial. Front Med (Lausanne). 2024 Feb 14;11:1238878. doi: 10.3389/fmed.2024.1238878. eCollection 2024.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Schneider, MD principal investigator
Department of Anaesthesiology, University Hospital of Basel (USB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLP-injection, Scripted Evidence-based treatment rationale and Experimental model of acute pain in people with Acute Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Schneider, MD (+41 61 328 65 43, tobias.schneider@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Change in Area under the Pain Curve (AUPC) (time frame: During three hours after administering an OLP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.